This page includes the latest FDA filings for T2 Biosystems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| USA | NASDAQ | TTOO | DUNS 803126320 |
| Registration Number | 3010097867 |
| FEI Number | 3010097867 |
| Name | T2 BIOSYSTEMS, INC. |
| Owner & Operator | T2 Biosystems, Inc. |
| Contact Address | 101 Hartwell Avenue Lexington MA 02421 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 101 Hartwell Ave Lexington, MA 02421 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
| T2 BIOSYSTEMS, INC. | T2Bacteria® QCheck Positive Kit | 2024-02-28 |
| T2 BIOSYSTEMS, INC. | T2Bacteria® Reagent Trays | 2024-02-28 |
| T2 BIOSYSTEMS, INC. | T2Bacteria® QCheck Negative Kit | 2024-02-16 |
| T2 BIOSYSTEMS, INC. | T2Biothreat® QCheck Negative Kit | 2023-11-15 |
| T2 BIOSYSTEMS, INC. | T2Biothreat® QCheck Positive Kit | 2023-11-15 |
| T2 BIOSYSTEMS, INC. | T2Biothreat® Reagent Trays | 2023-11-15 |
| T2 BIOSYSTEMS, INC. | T2Dx® | 2022-09-16 |
| T2 BIOSYSTEMS, INC. | T2Candida® Cartridge Kit | 2022-04-28 |
| T2 BIOSYSTEMS, INC. | T2Bacteria® Cartridge Kit | 2020-12-21 |
| T2 BIOSYSTEMS, INC. | T2Bacteria® Reagent Trays | 2020-12-21 |
| T2 BIOSYSTEMS, INC. | T2Dx® QCheck Negative Kit | 2020-02-26 |
| T2 BIOSYSTEMS, INC. | T2Dx® QCheck Negative Kit | 2020-02-19 |
T2 BIOSYSTEMS, INC. | T2Candida 1.1 Panel | 2018-06-22 |
T2 BIOSYSTEMS, INC. | T2Bacteria Panel | 2018-06-22 |
T2 BIOSYSTEMS, INC. | T2Bacteria Panel | 2018-06-22 |
T2 Biosystems, Inc. | T2Bacteria Panel | 2018-05-24 |
T2 Biosystems, Inc. | T2Candida 1.1 Panel | 2017-12-12 |
T2 BIOSYSTEMS, INC. | T2Dx Instrument | 2015-04-06 |
T2 BIOSYSTEMS, INC. | T2Candida Panel | 2015-04-06 |
T2 BIOSYSTEMS, INC. | T2Bacteria Panel | 2015-04-06 |
T2 BIOSYSTEMS, INC. | T2Dx Instrument | 2015-04-06 |
T2 BIOSYSTEMS, INC. | T2Candida Panel | 2015-04-06 |
T2 BIOSYSTEMS, INC. | T2Bacteria Panel | 2015-04-06 |
T2 BIOSYSTEMS, INC | T2CANDIDA AND T2DX INSTRUMENT | 2014-09-22 |
| NCAGE Code | 4ZDC8 | T2 BIOSYSTEMS, INC. |
| CAGE Code | 4ZDC8 | T2 BIOSYSTEMS, INC. |
| S.A.M. Registration | 4ZDC8 [803126320] | T2 BIOSYSTEMS, INC. |
| SEC | 0001492674 | T2 Biosystems, Inc. of DELAWARE |